AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.

Inclusion criteria

• Patient requiring intervention for the management of symptoms associated with acute cholecystitis
• Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health
• Eligible for endoscopic intervention
• Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines:

• AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met.
• AC Grade II (moderate) defined by any one of the following characteristics

• Leukocytosis (>18,000 cells per mm3)
• Palpable, tender mass in right upper quadrant
• Symptom duration >72 hours
• Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis)
• Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion
• 18 years of age or older
• Willing and able to comply with the study procedures and patient or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study

Exclusion criteria

• AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems:

• Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine
• Neurologic - decreased level of consciousness
• Respiratory - PaO2/FiO2 <300
• Renal - Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter)
• Hepatic - International normalized ratio >1.5
• Hematologic - Platelet count <100,000/mm3
• Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder
• Hepatic abscess
• Ascites
• Patients with abnormal coagulation or who require ongoing complete anticoagulation
• Bleeding diathesis
• History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)
• Patients with a current percutaneous drainage
• Patients with a history of percutaneous gallbladder drainage without AC free period following percutaneous drainage removal
• Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage
• Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location
• Patients that have allergies or are sensitive to any of the device materials
• Patients with contraindications to use of electrical devices
• Pregnancy
• Prisoners and other vulnerable populations